Skip to main content
OpenTrials
Completed

NCT Number: NCT03920332

Pregnancy and Fibrinogen Disorders

The aim of this observational study is to evaluate the prevalence of uncomplicated pregnancies in women suffering from congenital fibrinogen disorders (i.e, hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) as well as to describe pregnancies outcomes in such diseases.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypofibrinogenemia, Congenital Abortion, Spontaneous Afibrinogenemia Afibrinogenemia, Congenital Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dysfibrinogenemia, Congenital Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hopital Port-Royal, Paris, France

Loading trial locations.

About this study

Women with quantitative or qualitative fibrinogen disorders are often more prone to obstetrical complications, from bleeding to recurrent miscarriages or thrombosis. Data on fibrinogen levels variations throughout the pregnancy and on the delivery management are lacking. In this observational study will be include adult women with pas obstetrical history. A general questionnaire on demographics and clinical data will be filled out by the patient's physician. A detailed questionnaire on obstetrical data will also be completed contacting the patient in case of lacking data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inherited fibrinogen disorders (hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia)
  • At lest one past pregnancy
  • Adult

Exclusion criteria

  • No past pregnancy
  • Not confirmed fibrinogen disorder

Treatment and study plan

Primary outcomes

  1. Prevalence of normal issue pregnancy

    Time frame: At inclusion

    All pregnancy not resulting in miscarriage, stillbirth or abortion

Secondary outcomes

  1. Prevalence of pregnancy without complications

    Time frame: At inclusion

    All pregnancy not resulting in intrauterine growth retardation, preterm labor, pregnancy-induced hypertension, gestational diabetes, preeclampsia, abruption placenta, anamniota, vaginal bleeding requiring medical intervention

  2. Modalities of delivery

    Time frame: At inclusion

    Vaginal versus caesarean cut

  3. Modalities of delivery

    Time frame: At inclusion

    Instrumental delivery vs none

  4. Post-partum complications

    Time frame: At inclusion

    Post-partum haemorrhage and/or thrombotic event within 3 months after the delivery

  5. Fibrinogen variations

    Time frame: At inclusion

    Fibrinogen levels throughout the pregnancy

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Swiss Hemophilia Network

Registry information

Official study title

Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders

Acronym: FIBRINOGEST

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2019
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.